Director Quality Assurance Regulatory Affairs

Director of Quality Assurance and Regulatory Affairs

REPORTS TO

Chief Technology Officer

PRIMARY OBJECTIVES

The VP of Quality Assurance and Regulatory Affairs is responsible for ensuring compliance of the Quality Management System to 21 CFR 820 (Quality Management System Regulation), ISO 13485, 21 CFR Part 11, and all applicable regulations and standards. This individual acts as the management representative of the company when interfacing with the FDA and other health authorities.

ESSENTIAL JOB FUNCTIONS/RESPONSIBILITIES

• Serve as the management representative and ensure that top management is notified and made aware of any concerns involving compliance and/or product quality. Lead management review meetings and work cross-functionally with the team to schedule and prepare management review content/slides in compliance with applicable domestic and international regulatory requirements.
• Work collaboratively with stakeholders to implement the QMS to facilitate compliance with 21 CFR 820 (Quality System Regulation), ISO 13485, and 21 CFR Part 11. Oversee the Management Review process and ensure compliance with the FDA QMSR and ISO 13485 and applicable regulatory requirements.
• Determine regulatory strategies for new products and changes to products. Guide the design and development team on standards and regulations that should be taken into consideration when documenting design inputs. Perform and document gap analysis to new/revised regulatory requirements to drive QMS procedural updates.
• Work collaboratively with the teams to prepare, review, and/or approve product development documentation generated by team members/design partners, ensuring it is established per the design and development plan and maintained in the QMS (i.e., product specifications, design verification & validation activities, risk management documentation, test methods, process validation, design transfer, etc.).
• Work with the teams to develop and maintain Risk Management documentation in accordance with procedures throughout the product life-cycle. Ensure that PMS trending is performed and communicated cross-functionally and to top management on a regular basis.
• Ensure that complaint handling, adverse event reporting, and complaint investigation procedures are established and maintained. Facilitate returned product investigations and ensure that adverse events and field safety corrective actions are reported and conducted in a timely manner as required.
• Ensure that the Approved Supplier List (ASL) and supplier files are established and maintained. Work with team members to ensure that suppliers are qualified per established procedures. Oversee supplier corrective actions (SCARs), internal CAPAs, and NCMR processes per established procedures.
• Work closely with regulatory consultant group on FDA pre-submissions and other FDA product submissions.
• Manage regulatory audits and inspections and work with the team to ensure inspection readiness.
• Additional responsibilities may be assigned.

EDUCATION REQUIREMENTS

Bachelor’s degree in sciences, engineering or related discipline. Master’s degree preferred.

EXPERIENCE REQUIREMENTS

• Minimum of 12 years of experience in Quality Assurance and regulatory affairs in a medical device, preferably IVD, industry. Minimum of 5 years of direct management experience in medical device/IVD development.
• Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, 21 CFR 803 (MDR Reporting), 21 CFR 806, and IVD labeling/UDI requirements (clinical and production).
• Thorough knowledge of Quality System regulations.
• Familiarity with IEC 62304, IEC 60601.
• Experience in hosting and managing FDA and ISO inspections for medical device.
• Experience with FDA medical device submissions, preferably for IVDs.
• Experience with design transfer and quality operations supporting product launch.

REQUIRED SKILLS/QUALIFICATIONS

• Work directly with the R&D/Product Development team to build Quality into the product design.
• Strong analytical, problem-solving, and technical writing skills, including the ability to independently author quality and regulatory documentation.
• Experience with maintaining Medical Device Files.
• Experience implementing international standards in a medical device environment.
• Familiarity with statistical quality improvement and/or root cause analysis techniques.

PERSONAL TRAITS

• Works well under pressure, organized and self-motivated.
• Strong communication and interpersonal skills and ability to work effectively in teams.
• Reliable with a high attention to detail.
• Organized and resourceful.
• Ability to remain motivated with little supervision.
• Excellent project management skills.

TRAVEL REQUIREMENTS

Some travel may be required.